The suburethral sling technique for treatment of stress urinary incontinence has become the preferred treatment because the long term results are better in most cases than other treatment methods. The classic pubovaginal sling technique utilizes rectus fascia from the patient as the sling material for support of the urethra. The morbidity of rectus fascia pubovaginal sling procedures has caused surgeons to utilize alternative materials. Permanent non-absorbable materials have been deployed in one such alternative but have resulted in erosions of the synthetic material into the urethra and vagina. Also, infections of the sling have had serious complications because of the material being treated as a “foreign body”.
Cadaveric tissue has been used in an effort to avoid the problem of “foreign body” reactions resulting in infections and erosions. However, cadaveric fascia and cadaveric dermis have not had the same results as tissue derived from the patient at the time of surgery. Cadaveric fascia is a tissue remodeling material. That is, the human body recognizes the tissue as a familiar material and biochemically breaks down the tissue and rebuilds it as its own tissue. Unfortunately, during the breaking down period of the cadaveric tissue, the tissue strength often fails rendering support of the urethra inadequate. Consequently, the urethra “falls” back down and the sling fails. Remodeling tissue needs to have additional strength during the time of remodeling in order to avoid failure of the material due to material weakness. Once remodeling has occurred, the tissue is strong enough to provide a good result for a long time.
Biodegradable materials such as polylactate are available that are degraded by the body slowly over 18 months to 30 months. These materials can be made into a mesh to support the tissue remodeling materials through the period of remodeling. This leaves normal body tissue supporting the urethra that has resulted from the remodeling process. The biodegradable sling material such as polylactate is absorbed by the body and there is no “foreign body” to create erosions and infections.
Deployment of the current sling devices utilize complicated sling transfer instruments that cannot be well controlled by the surgeon. This has resulted in serious complications including perforation of bowel as well as injury to major arteries and veins causing death in young women who are otherwise healthy having a simple surgical procedure. It is critical that the sling transfer instrument be simplified and better control of the instrument be provided to the surgeon.
As the urethra prolapses or “falls down” resulting in loss of bladder control, the entire vaginal wall also prolapses or “falls down”. Current sling procedures do not provide any support for the anterior vaginal wall. One of the most common causes of re-operation after current sling procedures is a cystocele repair to repair the anterior vaginal prolapse that should progressively worsened after the sling placement. Current slings are not designed to repair the anterior vaginal wall at the same time the support of the urethra is done. A sling is needed that supports the entire functional urethra as well as the base of the bladder to prevent progression of vaginal prolapse.
The normal woman when in the standing has the urethra in a position that the axis through the urethra is 15 degrees to 35 degrees off a true vertical position. The pubic bone has an axis of about 45 degrees off a true vertical position. This makes the angle or the axis of the pubis and the angle of the axis of the urethra about 70 degrees to 90 degrees. The base of the bladder as it attaches to the urethra has a posterior angle of 90 degrees to 115 degrees. The contoured sling is designed to restore the urethro-vesical angle and to restore the axis of the urethra.
Deployment of contemporary sling devices utilize complicated sling transfer instruments that cannot be well controlled by the surgeon. This has resulted in serious complications including perforation of bowel as well as injury to major arteries and veins causing death in young women who are otherwise healthy having a simple surgical procedure. In keeping with the teachings of the instant invention, it is critical that a sling transfer instrument be simplified to allow enhanced instrument control by the surgeon.
Given the deficiencies of the contemporary art and the enhancement teachings of the instant invention, it is an object of the instant invention to provide a tubular mesh sling for incontinence which eliminates urethral obstruction and voiding difficulties associated with slings and tapes of the contemporary art.
It is another object of the instant invention to provide an incontinence solution which avoids the morbidity associated with rectus fascia tissue transplanted from the abdomen to the vagina of a patient and the long term durability deficiencies of cadaveric tissue as used in the contemporary art.
It is a further object of the instant invention to provide an incontinence solution which avoids the numerous and serious complications from intra-operative injury to organs in the pelvis.
It is yet another object of the instant invention to avoid paravaginal dissection required of surgical instruments and methodologies associated with the contemporary art.
A further object of the instant invention is to provide an incontinence solution which is embodied as a sling design conforming to the anatomical variations of the urethra of women who have urinary incontinence.
A yet further object of the instant invention is to provide a knit mesh pubovaginal sling which conforms to the anatomy of the urethra and anterior vaginal wall when the anatomy of a patient is distorted by urethral prolapse or previous vaginal surgery.
Another object of the instant invention is to present a mesh sling embodiment in a component structure that has an anterior surface which attaches to the vaginal wall adjacent to the urethra and a posterior surface which attaches to the vaginal mucosa.
An additional object of the instant invention is to provide an incontinence solution in a mesh sling form which avoids buckling due to opposing forces of the vaginal wall and vaginal mucosa on the sling.
A further object of the instant invention is to provide a mesh sling which has an anterior and posterioral layer which provides greater tensile strength compared to tape mesh slings of the contemporary art.
Yet another object of the instant invention is to provide a mesh sling design which demonstrates a significant degree of elasticity of the sling material.
A further object of the instant invention is to provide a tubular mesh sling which embodies a dual continence design and can be positioned to support both the mid-urethra and bladder neck sphincteric continence sites.
Another object of the instant invention is to provide a sling comprised in part of tissue remodeling material where sufficient support is provided to tissue remodeling material during biochemical breakdown of the tissue and rebuilding.
Another object of the instant invention is to provide a sling which is comprised of biodegradable materials and tissue remodeling materials.
A further object of the present invention is to disclose and teach a sling transfer instrument which allows enhanced sling deployment control by a surgeon.
Another object of the instant invention is to teach a method and apparatus for sling deployment utilizing either suprapubic, transvaginal or obturator fossa deployment methodologies.
A further object of the instant invention is an anterior vaginal sling that restores anatomical support to both the mid-urethral continence sphincteric function and the bladder neck continence sphincteric function.
Another object of the instant invention is an anterior vaginal sling that restores the anatomical relationship of the urinary bladder to the urethral by providing confluent support to the base of the bladder and the proximal urethra.
A further object of the instant invention includes an anterior vaginal sling that is contoured to restore the normal anatomical position of the mid-urethra, the proximal urethra, the bladder neck, and the base of the bladder which not only restores the normal continence sphincteric function of the urethra but also restores normal bladder function relative to the urethra.
Yet another object of the invention provides an anterior vaginal sling composed of biodegradable mesh or non-biodegradable mesh in any non-proprietary weave configuration.
An object of the instant invention provides an anterior vaginal sling design using biodegradable mesh reinforced tissue remodeling material with the biodegradable mesh combined with tissue remodeling material to provide tensile strength for the tissue remodeling material during an interval of tissue weakness due to the process of remodeling. The biodegradable material can be layered, stranded, or randomly combined with tissue remodeling materials.
Still yet, another object of the instant invention provides a sling transfer instrument that has a progressively curved shaft portion and a sharply curved tip that allows the instrument to be passed through the retropubic space with a reduced risk of organ perforation.
Further, an object of the instant invention provides the sling has supporting ribs throughout the distal part of each end of the sling to secure the sling to surrounding tissues and to allow for sling tension adjustment.
Another object of the instant invention includes a biodegradable tab which is located at the middle of the sling and extends through the vaginal mucosa postoperatively to allow loosening of the sling tension postoperatively if necessary.
A further object of the instant invention provides that the distal segment of each end of the sling is left in place postoperatively to allow tightening of sling tension if necessary. An attachable handle is used postoperatively for sling tension adjustment.
Yet another object of the present invention provides a spring design sling tension adjustment instrument that is used intra operatively to insure proper sling tension.
A further object of the present invention provides an extended embodiment of the sling that is used to provide support to the proximal segment of the anterior vagina to support cystocele repair.
An additional object of the present invention provide that the sling transfer instruments are designed with a luminous coating for easy identification during cystoscopy should perforation of the bladder occur.
Another object of the present invention is to provide a sling transfer instrument with detachable insertion handle designed to provide maximum control to the surgeon of the instrument tip to avoid organ perforation. Finger grips and a specially designed thumb control feature of the handle provides accuracy of tip placement.
An alternative object of the present invention provides that the embodiment of the sling transfer instrument design is used for placement from a suprapubic position through the prevesical space into the vagina. The sling is attached to the tip of the instrument and transferred to the suprapubic position.